Three Synthes Executives Sentenced to Prison Time

Published Date: November 22, 2011 04:17:00 AM EST
Author: By David Sell, The Philadelphia Inquirer

Nov. 22--Three former executives of medical-device manufacturer
Synthes Inc. were sentenced to prison Monday. A fourth might have
been if his attorney hadn't collapsed while standing at a lectern
moments after saying that Synthes' unindicted board chairman was
the ultimate authority and responsible for the illegal, sometimes
fatal bone-cement trial at the crux of the proceedings.

Michael Huggins, 54, of West Chester, former president of
Synthes USA, was sentenced to nine months in prison and taken into
custody immediately. Thomas Higgins, 55, of Berwyn, former leader
of Synthes' spine division, got the same sentence. John Walsh, 48,
of Coatesville, who was in charge of regulatory affairs, got five
months.

U.S. District Judge Legrome D. Davis gave Higgins two weeks to
report to prison, so he can arrange for extra medical care for his
wife. Davis gave Walsh until next Monday to report because Tuesday
is his young daughter's birthday.

The three will pay $100,000 each in fines and be on supervised
release after prison. All pleaded guilty to a single misdemeanor
count under the responsible-corporate-officer doctrine.

Richard Bohner, 56, of Malvern, former vice president for
operations, was the third of four on Davis' docket Monday and might
have gotten a sentence similar to that received by Huggins and
Higgins.

But as one of his attorneys, Brent Gurney, was making the case
for why Bohner should get only probation, Gurney collapsed and hit
his head on a nearby table. He was given medical attention,
including a bandage, because he was bleeding from the back of his
head. Within a few minutes, Gurney was moving his hands, and he was
conscious as paramedics wheeled him from the sixth-floor courtroom
at the federal courthouse and off to Thomas Jefferson University
Hospital.

Davis continued Bohner's case, and his sentencing will be
rescheduled.

Synthes is a Swiss-based company with facilities and U.S.
headquarters in West Chester. It is being acquired by health-care
giant Johnson & Johnson for $21.3 billion.

Medical-device and pharmaceutical companies have paid billions
of dollars to settle criminal charges over the years, but rarely do
their executives go to jail. This time was different because
prosecutors showed, with the help of thousands of pages of internal
Synthes documents, that executives were actively involved in the
illegal promotion and clinical testing of its Norian bone cements
used by doctors in back surgeries, three of which ended with
patients dying on the operating table.

Davis said Huggins, the highest-ranking executive of the four,
showed a "knowing disregard" for the safety of patients.

"You are being punished for the decisions you made and
personally participated in," the judge told Huggins in a packed
courtroom for the first sentencing hearing.

Huggins did not speak at the hearing, and one of his attorneys,
Greg Poe, declined comment after the sentence was delivered.

The same was true for Higgins and one of his attorneys, Adam
Hoffinger.

One of Walsh's attorneys, William Lawlor, read a statement from
Walsh during the hearing and suggested there might be an appeal on
First Amendment grounds. Both declined comment afterward.

"The First Amendment is not what this is about," Davis said.

A former Synthes doctor, upon learning of the unauthorized
bone-cement trial, called it human experimentation because of the
relatively ad-hoc process and because patients and some surgeons
were not given the information required to make an informed
choice.

"The government is pleased with the sentences," said lead
prosecutor Mary Crawley, of the U.S. Attorney's Office in
Philadelphia. "We believe it sends the right message to
medical-device and drug companies that lying to the FDA and
disregarding patient safety has consequences."

Hansjorg Wyss, the Synthes board chairman who also was chief
executive officer when the illegal bone-cement trial occurred, was
not in the courtroom, but still he was part of Monday's events.

Gurney, Bohner's attorney, said Wyss was the undisputed leader
of the company. "He made some of the very critical decisions that
put the trials on the ultimate pathway," Gurney said. "The culture
of an organization is set at the top."

Wyss could not be reached for comment.

Because he was not a defendant, Davis did not spend a lot of
time discussing Wyss. But the judge turned Gurney's comments back
on Bohner after the attorney mentioned several things Bohner should
not have been held responsible for, and he suggested a bit of
bravery was in order to help save patients' lives.

"Why did he always miss what the right thing was?" Davis asked,
adding that all of it amounted to "shameful behavior."

Contact staff writer David Sell at 215-854-4506 or dsell@
phillynews.com or Twitter @ phillypharma. Read his blog at
www.philly.com/phillypharma.

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